Non-invasive Glioma Characterization Through Molecular Imaging

Not Applicable

Recruiting

• Conditions: Glioma; Primary Brain Tumor; Malignant Primary Brain Tumor; Brain Tumor; Malignant Glioma
• Interventions: Device: 3T MRI Scanner

• Registration Number: NCT03684109
• Lead Sponsor: University of Miami

Brief Summary

MRI-based sequences can provide non-invasive quantification of intratumoral 2-hydroxyglutarate (2HG) distribution and tumor cellularity in human gliomas and help guide the development of novel glioma therapies.

Detailed Description

This is a pilot study aiming at developing and optimizing MRI-based sequences to provide non-invasive quantification of intratumoral 2-hydroxyglutarate (2HG) distribution and tumor cellularity in human gliomas and help guide the development of novel glioma therapies.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-21
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-25
• Study Start: 2019-01-25
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adults (≥18 year old)
• Subjects with suspected or confirmed gliomas and who will have a medically indicated biopsy or resection of his/her brain lesion.

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Exclusion Criteria

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Patients unable to have MRI done

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IDH-Mutant Glioma Patients	3T MRI Scanner	Patients who have suspected or confirmed gliomas and are scheduled to undergo biopsy or resection of their brain tumors will receive a 3 Tesla (3T) Magnetic Resonance Imaging (MRI) scan of their brain.

Primary Outcome Measures

Name	Time	Method
2HG Concentration via 3T MRI Scanner	Day 1	2HG concentrations as measured via 3T MRI Scanner.
2HG Concentration from tissue samples	Day 1	2HG concentrations as measured via patient's surgically excised tissue sample ex vivo by tissue based liquid chromatography-mass spectrometry (LC-MS)

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States